Trials Sponsors Conditions Drugs Pricing

Conditions

Helicobacter Pylori

Keywords

Helicobacter pyloriH. pyloriRandomized Intervention StudyCYP2C19antibiotic susceptibilitypersonalized treatment

Outcome Measures

Primary Outcomes (1)

H. pylori eradication success
The primary outcome is H. pylori eradication success, defined as negative post-treatment H. pylori stool antigen (HPsAg) testing. Post-treatment persistent positive HPsAg indicates eradication treatment failure; equivocal tests will be conservatively counted as a treatment failure, along with participants who fail to complete follow up testing within the prespecified timeframe (intention-to-treat analysis). All participants must be off proton pump inhibitors (PPIs) for a minimum of 2 weeks, and off antibiotics or bismuth for at least 4 weeks prior to HPsAg testing. HPsAg testing will be performed between 4-6 weeks post-treatment.
4-6 weeks after treatment

Secondary Outcomes (2)

Treatment adherence
Weeks 1 and 2 after treatment initiation
Treatment-emergent side effects/adverse events
Weeks 1 and 2 after treatment initiation, 6 weeks after treatment completion

Study Arms (2)

Personalized bismuth-based quadruple therapy or clarithromycin triple therapy

EXPERIMENTAL

Participants allocated to the experimental group receive a personalized treatment based on clarithromycin (CLR) and amoxicillin susceptibility and CYP2C19 metabolizer profile status as follows: 1. CLR or amoxicillin resistant/CYP2C19 normal/rapid/ultrarapid metabolizers receive bismuth quadruple therapy (BQT) with optimized PPI (bismuth 524 milligrams QID, metronidazole 500 milligrams QID, tetracycline 500 milligrams QID, and omeprazole 20 milligrams QID) for 14 days. 2. CLR or amoxicillin resistant/CYP2C19 intermediate/poor metabolizers receive BQT with standard PPI (BQT + omeprazole 20 mg BID) for 14 days. 3. CLR and amoxicillin susceptible/CYP2C19 normal/rapid/ultrarapid metabolizers receive CLR triple therapy with optimized PPI (amoxicillin 1000 mg BID, clarithromycin 500mg BID, and omeprazole 20mg QID) for 14 days. 4. CLR and amoxicillin susceptible/CYP2C19 intermediate/poor metabolizers receive CLR triple therapy with standard PPI (CLR triple therapy + omeprazole 20mg BID).

Drug: Bismuth quadruple therapy with optimized proton pump inhibitor (PPI)Drug: Bismuth quadruple therapy with standard proton pump inhibitor (PPI)Drug: Clarithromycin triple therapy with optimized proton pump inhibitor (PPI)Drug: Clarithromycin triple therapy with standard PPI

Interventions

Bismuth quadruple therapy with optimized proton pump inhibitor (PPI)Drug

Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams QID for 14 days.

Personalized bismuth-based quadruple therapy or clarithromycin triple therapy

Bismuth quadruple therapy with standard proton pump inhibitor (PPI)Drug

Bismuth 524 milligrams QID, Metronidazole 500 milligrams QID, Tetracycline 500 milligrams QID, and Omeprazole 20 milligrams (active BID + placebo BID) for 14 days. \*\*NOTE: placebo tablets are used to maintain the same number of pills in all study arms and preserve blinding

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult Veterans, irrespective of sex/gender (male, female, non-binary, other preferred classification)
Treatment-naïve patients with active H. pylori infection as determined by a positive H. pylori stool antigen (HPsAg), gastric biopsy, or urease breath test. All individuals who test positive based on a non-HPsAg modality will need to have a positive HPsAg documented within 4 weeks of enrollment to be considered eligible

Sponsors & Collaborators

San Diego Veterans Healthcare System
US federal agencycollaborator
VA Office of Research and Development
US federal agencylead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Shailja Shah, MD MPHCONTACT(858) 552-8585 shailja.shah@va.gov

Shailja Shah, MD MPHPRINCIPAL INVESTIGATOR

Study Officials

Shailja Shah, MD MPH
VA San Diego Healthcare System, San Diego, CA
PRINCIPAL INVESTIGATOR

Central Study Contacts

Shailja Shah, MD MPH

CONTACT

(858) 552-8585 shailja.shah@va.gov

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: FED
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

January 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

March 31, 2029

You may not qualify if:

The investigators will exclude individuals with:
Conditions where urgent H. pylori treatment is recommended (i.e., active peptic ulcer disease (PUD) complicated by bleeding, perforation, or obstruction; gastric neoplasia including MALT lymphoma). Active PUD is defined as having a gastric or duodenal ulcer confirmed on an upper endoscopic procedure in the 4 weeks prior to eligibility determination
Inability to be safely off of PPI for two weeks to allow for accurate post-treatment HPsAg testing. These conditions include Barrett's esophagus with dysplasia, active PUD, severe esophagitis defined as Los Angeles Classification C or D esophagitis
Allergy or severe intolerance/contraindication to any of the treatment components. Note: In patients with penicillin allergy, metronidazole is often substituted for amoxicillin in PPI clarithromycin triple therapy. However, this alternative regimen demonstrates higher failure rates vs. PPI-clarithromycin triple therapy with amoxicillin among Veterans and thus the investigators elected to exclude patients with penicillin allergy.
Severe medical comorbidity that is a threat to life. This includes, but is not limited to, coronary artery disease with myocardial infarction or equivalent (e.g., cerebrovascular event) within 12 months, unstable angina or congestive heart failure, cardiac or vascular stent placement within 12 months, chronic obstructive pulmonary disease requiring home oxygen, decompensated cirrhosis, end-stage renal disease, other diseases that limit life expectancy to less than 5 years.
Any prior history of upper gastrointestinal surgery or gastric cancer diagnosis
Past liver transplant or allogenic bone marrow transplant, given that pharmacogenomic testing is inaccurate for these patients
Any history of recurrent Clostridioides difficile infection (CDI), defined as an episode of CDI occurring within 8 weeks of a previous CDI episode; or any episode of CDI within the preceding 12 months
Evidence of any overt gastrointestinal bleeding
History of photosensitive reactions to any medications
Women who are pregnant, lactating, or of childbearing age without reliable contraception (Note: all women of childbearing age will be asked to submit a urine pregnancy test prior to enrollment)
Prior CYP2C19 or PHASER testing or HP antimicrobial susceptibility profiling before enrollment

Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Personalized bismuth-based quadruple therapy or clarithromycin triple therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Standard bismuth-based quadruple therapy

You may not qualify if:

Data Sharing

Source record

Locations

Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Personalized bismuth-based quadruple therapy or clarithromycin triple therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Standard bismuth-based quadruple therapy

You may not qualify if:

Data Sharing

Source record

Locations